Pulmonary diseases and disorders continue to pose major health care concerns. According to the American Lung Association, pulmonary diseases and other breathing problems were the third leading cause of death in the United States in 2003, responsible for one in seven deaths, with more than 35 million Americans suffering from chronic pulmonary diseases.
Pulmonary diseases and disorders are of either an obstructive or restrictive nature. Obstructive breathing diseases are caused by a blockage or obstacle in the airway due to injury or disease, such as asthma, chronic bronchitis, emphysema, or advanced bronchiectasis. Restrictive breathing disorders are caused by muscular weakness, a loss of lung tissue or when lung expansion is limited as a result of decreased compliance of the lung or thorax. The conditions that can result in a restrictive breathing disorder include pectus excavatum, myasthenia gravis, diffuse idiopathic interstitial fibrosis, and space occupying lesions, such as tumors and effusions. Proper treatment of pulmonary diseases and disorders requires early identification and on-going monitoring of pulmonary performance.
Conventionally, pulmonary performance is tested in a clinical setting to establish certain baseline values indicative of the ability of the lungs to exchange oxygen and carbon dioxide during normal breathing. Pulmonary performance can be established by testing pulmonary volumes using a spirometer during inspiration and expiration, as measured under normal and forced conditions. Spirometric testing can determine tidal volume (VT), which is the volume inhaled or exhaled in normal quiet breathing; inspiratory reserve volume (IRV), which is the maximum volume that can be inhaled following a normal quiet inhalation; expiratory reserve volume (ERV), which is the maximum volume that can be exhaled following a normal quiet exhalation; and inspiratory capacity (IC), which is the maximum volume that can be inhaled following a normal quiet exhalation.
In addition, functional residual capacity (FRC), which is the volume remaining in the lungs following a normal quiet exhalation, can be measured by introducing helium into a closed spirometer at the end of a normal quiet exhalation and determining FRC from helium concentration upon reaching equilibrium. However, for patients suffering from obstructive respiratory disorders, such as emphysema, the helium dilution technique can underestimate FRC. Alternatively, FRC can also be measured through body plethysmography.
Pulmonary performance testing in a non-clinical setting is difficult. Testing requires the same equipment as required in-clinic. Moreover, ensuring that the battery of pulmonary performance tests, in particular, forced expiration, is accurately and consistently administered can be difficult for lay people. Consequently, ambulatory pulmonary performance testing results generally lack a sufficient degree of reliability for use in medical diagnosis and treatment. Implantable medical devices facilitate ambulatory in situ physiological testing and monitoring, but conventional applications of implantable medical device measurement failed to provide an adequate solution to ambulatory pulmonary performance testing.
U.S. Patent Application Publication No. US2002/0123674, filed Feb. 27, 2002, by Plicchi et al., describes an implantable medical device capable of detecting the physiological properties of pulmonary tissue, which are dependent on the density and variations caused by the pathologic condition of the heart. Intrapulmonary catheters with sensors are inserted into pulmonary arteries. The sensors allow ambulatory monitoring of electrocardiographic (ECG) signals without the artifacts or interferences, such as myoelectric artifacts and muscular tremors, occasioned by the use of external ECG sensors. However, the placement of intrapulmonary catheters is highly invasive and the approach relies upon the bioelectric impedance of the pulmonary tissues to precisely measure R-waves and related physiological signals. Moreover, the Plicchi device is focused on determining lung density and fluid volume and not on measuring transthoracic impedance to determine pulmonary volume and rates.
U.S. Pat. No. 5,957,861, issued Sep. 28, 1999 to Combs et al., describes an implantable edema monitor with a pair of electrically isolated electrodes implanted in subcutaneous regions of the body. Energy pulses are delivered from the housing of the monitor to the electrodes to determine pulmonary impedance. The monitor can be used with pacemakers or other implantable cardiac devices. The monitor stores short term and long term average impedance values and identifies diagnostically significant events. However, the Combs monitor focuses on sensing impedance as an indication of edema and not on deriving volumetric or rate values relating to cardiopulmonary functioning.
U.S. Pat. No. 5,522,860, issued Jun. 4, 1996 to Molin et al., describes an implantable medical device that counts noise events occurring due to parasitic electromagnetic signals. In one embodiment, if the noise values are too high or there is too much noise at unacceptable levels, an acquired pulmonary impedance value may be discarded as being unreliable. The Molin device focuses on sensed physiological values, not volumetric and rate-related cardiopulmonary values, and whether to suspend operation due to noise levels exceeding predefined thresholds.
U.S. Pat. No. 5,003,976, issued Apr. 2, 1991 to Alt, describes an apparatus for deriving the physiological activities of a patient through detection and analysis with a single sensor implanted in the vascular system of the patient. The pulmonary activities are derived from differences in cardiac activities, including blood flow, pressure and volume changes, and performance measures observed through right heart impedance changes. The Alt device relies on a single functional parameter, intracardiac impedance, that is representative of both cardiac and pulmonary activity and as distinguished through the use of high pass and low pass filters. However, the Alt device only measures impedance with respect to pulmonary activities derived from measures collected through the vascular system and not through transthoracic sensors representative of volumetric or rate-related cardiopulmonary values.
Therefore, there is a need for an approach to assessing pulmonary performance by measuring volumetric and rate profile data through transthoracic impedance, particularly as related to the performance of a forced expiration maneuver. Preferably, such an approach would facilitate analyzing pulmonary performance in a non-clinical setting on a regular basis for use in automated pulmonary and cardiopulmonary disease patient measurement.